Clinical trials: Valvular Heart Disease
Severe, Symptomatic
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
- Conditions
- Severe, Symptomatic, Calcific Aortic Stenosis
- Trial name
- PARTNERII B (NCT02184442)
- Testing
- TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN
- Where
- 53 sites in United States
- Volunteers
- 560 people
- Sponsor
- Edwards Lifesciences
Nonobstructive Hypertrophic Cardiomyopathy
Transapical Beating-Heart Septal Myectomy in Patients With Symptomatic Nonobstructive Hypertrophic Cardiomyopathy
The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of nonobstructive hypertrophic cardiomyopathy.
- Trial name
- NCT05952154
- Testing
- Transapical beating-heart septal myectomy
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Xiang Wei
Aortic Valve Stenosis
Platelet Adhesion in the Pathobiology of Aortic Stenosis
Aortic stenosis (AS) is a serious and common condition that affects 2-3% of the population >65 years of age in Western countries.
- Trial name
- NCT05550896
- Testing
- Echocardiogaphy
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- University of Virginia
Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty
Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence
The aim of this study is to evaluate feasibility, efficacy, and adherence of home-based cardiac rehabilitation with the integration of telemedicine.
- Conditions
- Myocardial Infarction, Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Bypass, Stable Angina
- Trial name
- NCT05972070
- Testing
- ROMTech Portable Connect
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- ROM Technologies, INC
Atrial Fibrillation
The Comparative Safety and Effectiveness of Dabigatran, Versus Rivaroxaban, and Apixaban Utilized in the Department of Defense Non-Valvular Atrial Fibrillation Patient Population: A Retrospective Database Analysis
The purpose of this study is to assess the safety and effectiveness of newly initiated dabigatran among patients diagnosed with non valvular atrial fibrillation (NVAF) in comparison to newly initiated rivaroxaban users and newly…
- Trial name
- NCT03026556
- Testing
- Dabigatran vs. Rivaroxaban, Dabigatran vs. Apixaban
- Where
- United States
- Volunteers
- 42,534 people
- Sponsor
- Boehringer Ingelheim
Mitral Regurgitation, Mitral Valve Disease
Multicenter Post-Market Observational Registry of the NeoChord Artificial Chordae Delivery System
The objective of this study is to evaluate the 5-year outcomes of participants with degenerative mitral valve disease treated with the NeoChord Artificial Chordae System, Model DS1000 in a post-market setting.
- Conditions
- Mitral Regurgitation, Mitral Valve Disease, Mitral Valve Insufficiency, Mitral Valve Prolapse
- Trial name
- AcChord (NCT04190602)
- Testing
- NeoChord Artificial Chordae Delivery System, Model DS1000
- Where
- 5 sites in Germany, Greece and 1 more
- Volunteers
- 500 people
- Sponsor
- NeoChord
HCM - Hypertrophic Cardiomyopathy
Effect of Henagliflozin on Myocardial Fibrosis in Non-Obstructive HCM: A Randomized, Double-Blind, Placebo-Controlled Trial Using 68Ga/18F-FAPI PET/CMR
his is a single-center, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effect of Henagliflozin (an SGLT2 inhibitor) on myocardial fibrosis burden in patients with non-obstructive hypertrophic…
- Trial name
- NCT07294495
- Testing
- Henagliflozin (SGLT2 Inhibitor)
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai East Hospital
Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR)
ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent
To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow…
- Conditions
- Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease
- Trial name
- NCT03130777
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
- Where
- 14 sites in United States
- Volunteers
- 86 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Stenosis
VitaFlow LIBERTY Europe
This is a prospective, single-arm, multi-center, observational, post-market clinical investigation to document the clinical safety and performance of MicroPort CardioFlow VitaFlow Liberty™ Transcatheter Aortic Valve System in the…
- Trial name
- NCT06535659
- Testing
- VitaFlow Liberty™ Transcatheter Aortic Valve System
- Where
- 9 sites in Ireland, Italy and 3 more
- Volunteers
- 222 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Mitral Valve Insufficiency, Coronary Stenosis
Impact of Mitral Regurgitation on Coronary Haemodynamics and Instantaneous Effect of Transcatheter Mitral Valve Repair
In the present study, the investigators aim to use the in-vivo Transcatheter Mitral Valve Repair (TMVR) model to determine how Mitral Regurgitation (MR) affects coronary hemodynamics in patients affected with severe MR and…
- Conditions
- Mitral Valve Insufficiency, Coronary Stenosis, Mitral Regurgitation, Coronary Artery Disease
- Trial name
- MitraFLOW (NCT04245956)
- Testing
- Measure of hemodynamic indices in a stenosed coronary artery using a pressure wire
- Where
- Switzerland
- Volunteers
- 1 people
- Sponsor
- University Hospital, Geneva
Aortic Stenosis
Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis
To assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with low-gradient, severe aortic stenosis.
- Trial name
- NCT02010177
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Sheba Medical Center
Aortic Valve Disease, Valve Heart Disease
Freestyle-Perimount Calcification Comparison
The aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount…
- Trial name
- NCT04359030
- Testing
- Multislice CT scanning for aortic wall calcification, Transthoracic stress echocardiography
- Where
- Belgium
- Volunteers
- 90 people
- Sponsor
- Ziekenhuis Oost-Limburg
Valvular Heart Disease
Mechanism and Effect of Novel Metabolites on Valvular Heart Disease
Valvular heart disease (VHD) is a leading cause of loss of physical function, reduced quality of life and increased longevity.The epidemiology of VHD varies widely across the globe, with functional and degenerative diseases…
- Trial name
- Hestia (NCT07065500)
- Where
- China
- Volunteers
- 4,000 people
- Sponsor
- Sun Yat-sen University
Heart Valve Diseases, Aortic Valve Stenosis
BIOVALVE - I / II Clincial Investigation
First-in-Human clinical investigation to evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team…
- Trial name
- BIOVALVE (NCT02249000)
- Testing
- BIOVALVE prosthesis
- Where
- 13 sites in Belgium, Germany and 2 more
- Volunteers
- 68 people
- Sponsor
- Biotronik AG
Cardiac Amyloidosis, Amyloidosis in Transthyretin (TTR)
Prevalence of Transthyretin Amyloidosis in Hypertrophic Cardiomyopathy
Cardiac amyloidosis are related to the accumulation of fibrillar proteins in the extracellular leading to disruption of the cardiac tissue architecture.
- Conditions
- Cardiac Amyloidosis, Amyloidosis in Transthyretin (TTR), Hypertrophic Cardiomyopathy (HCM)
- Trial name
- Amylo (NCT01623245)
- Where
- France
- Volunteers
- 294 people
- Sponsor
- Thibaud Damy
Mitral Regurgitation, Mitral Valve Prolapse
Ventricular Arrhythmias in Patients Undergoing Mitral Valve Surgery
Study objectives: To assess the impact of mitral valve surgery for mitral regurgitation on ventricular arrhythmic burden and surrogate markers of fibrosis in patients with arrhytmogenic mitral valve prolapse (MVP) from baseline…
- Conditions
- Mitral Regurgitation, Mitral Valve Prolapse, Ventricular Tachycardia
- Trial name
- Mitra-VT (NCT06255457)
- Testing
- Mitral valve surgery
- Where
- Sweden
- Volunteers
- 90 people
- Sponsor
- Karolinska Institutet
Mitral Valve Insufficiency, Heart Failure
Carillon Mitral Contour System® for Reducing Functional Mitral Regurgitation
The objective of this prospective, multi-center, randomized, double-blind trial is to assess the safety and efficacy of the Carillon Mitral Contour System in treating functional mitral regurgitation (FMR) associated with heart…
- Trial name
- REDUCE FMR (NCT02325830)
- Testing
- Carillon Mitral Contour System
- Where
- 31 sites in Australia, Czechia and 6 more
- Volunteers
- 163 people
- Sponsor
- Cardiac Dimensions Pty Ltd
Obstructive Hypertrophic Cardiomyopathy, Healthy Adult Subjects
Safety, Tolerability and Pharmacokinetics Study of CK-3773274
The purposes of this study are to: 1. Learn about the safety of CK-3773274 after a single dose and multiple doses in Chinese healthy adult subjects. 2.
- Trial name
- NCT04783766
- Testing
- CK-3773274
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Corxel Pharmaceuticals
Aortic Stenosis
ACURATE TA™ Valve Implantation Registry: SAVI 2
Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to collect continued surveillance data pertaining to…
- Trial name
- TA-SAVI2 (NCT02663375)
- Testing
- ACURATE TA™ Transapical Aortic Bioprosthesis
- Where
- 27 sites in Austria, Germany and 2 more
- Volunteers
- 250 people
- Sponsor
- Symetis SA
Aortic Stenosis, Amyloid
Atrial Amyloid May Influence Outcomes in Patients Undergoing Surgical Aortic Valve Replacement
Background (Context): Some older adults who undergo surgery to replace a narrowed heart valve (called aortic stenosis) may also have small protein deposits in their heart.
- Trial name
- AORTICMARKER (NCT07105501)
- Where
- Spain
- Volunteers
- 110 people
- Sponsor
- Germans Trias i Pujol Hospital